药品冷链物流操作规范

NowthatwehavereceivedfinalregulatoryapprovalfortheWyethacquisition,theIntegrationTeamhasauthorizedbusiness,functionalanddivisionalleaderstomakeorganizationalannouncementstosupportbusinesscontinuityandfacilitateourtransitiontoonecompany.ItisimportanttonotethattheseorganizationalchangeswillnotbecomeeffectiveuntilGlobalDayOneortherelevantin-countryGo-Livedate.Untilthattime,PfizerandWyethmustcontinuetooperateastwoseparatecompanies.Theprocessofstaffingandannouncingappointmentsacrossourbusinesseswillvarybymarketandaredependentonemployeeconsultationwithworkscouncilsand/orunionsinsomecountries.ExacttimelineswillalsovarybasedonbusinessneedsandcarefulassessmentbyregionalandlocalleadershipandlocalCountryIntegrationPlanningCouncils(CIPCs),onanongoingbasis.ConfidentialandInternal-subjecttoworkscounciland/orunionconsultationsandotherlegalrequirements.PPU2QA(Dev/MIR/Processaudit/Commitmenttracking)南京Nov.2010《江苏省药品冷链物流操作规范》NowthatwehavereceivedfinalregulatoryapprovalfortheWyethacquisition,theIntegrationTeamhasauthorizedbusiness,functionalanddivisionalleaderstomakeorganizationalannouncementstosupportbusinesscontinuityandfacilitateourtransitiontoonecompany.ItisimportanttonotethattheseorganizationalchangeswillnotbecomeeffectiveuntilGlobalDayOneortherelevantin-countryGo-Livedate.Untilthattime,PfizerandWyethmustcontinuetooperateastwoseparatecompanies.Theprocessofstaffingandannouncingappointmentsacrossourbusinesseswillvarybymarketandaredependentonemployeeconsultationwithworkscouncilsand/orunionsinsomecountries.ExacttimelineswillalsovarybasedonbusinessneedsandcarefulassessmentbyregionalandlocalleadershipandlocalCountryIntegrationPlanningCouncils(CIPCs),onanongoingbasis.ConfidentialandInternal-subjecttoworkscounciland/orunionconsultationsandotherlegalrequirements.江苏省药品冷链物流操作规范-草案范围规范性引用文件术语和定义基本要求收货和验收贮藏、养护、运输设备、设施验证保温包装系统的开发和管理培训体系质量管理要求NowthatwehavereceivedfinalregulatoryapprovalfortheWyethacquisition,theIntegrationTeamhasauthorizedbusiness,functionalanddivisionalleaderstomakeorganizationalannouncementstosupportbusinesscontinuityandfacilitateourtransitiontoonecompany.ItisimportanttonotethattheseorganizationalchangeswillnotbecomeeffectiveuntilGlobalDayOneortherelevantin-countryGo-Livedate.Untilthattime,PfizerandWyethmustcontinuetooperateastwoseparatecompanies.Theprocessofstaffingandannouncingappointmentsacrossourbusinesseswillvarybymarketandaredependentonemployeeconsultationwithworkscouncilsand/orunionsinsomecountries.ExacttimelineswillalsovarybasedonbusinessneedsandcarefulassessmentbyregionalandlocalleadershipandlocalCountryIntegrationPlanningCouncils(CIPCs),onanongoingbasis.ConfidentialandInternal-subjecttoworkscounciland/orunionconsultationsandotherlegalrequirements.基本要求•从事药品经销事业的质量管理人员的职业素质•以客户为中心，寻求超越顾客的期望值•对产品的熟悉程度、产品知识培训，产品的热稳定性性能•质量管理体系：变更和偏差管理•验证：冷库、冰箱、包装系统、运输验证•培训体系的建立•供应商、承运商等合作伙伴的审计NowthatwehavereceivedfinalregulatoryapprovalfortheWyethacquisition,theIntegrationTeamhasauthorizedbusiness,functionalanddivisionalleaderstomakeorganizationalannouncementstosupportbusinesscontinuityandfacilitateourtransitiontoonecompany.ItisimportanttonotethattheseorganizationalchangeswillnotbecomeeffectiveuntilGlobalDayOneortherelevantin-countryGo-Livedate.Untilthattime,PfizerandWyethmustcontinuetooperateastwoseparatecompanies.Theprocessofstaffingandannouncingappointmentsacrossourbusinesseswillvarybymarketandaredependentonemployeeconsultationwithworkscouncilsand/orunionsinsomecountries.ExacttimelineswillalsovarybasedonbusinessneedsandcarefulassessmentbyregionalandlocalleadershipandlocalCountryIntegrationPlanningCouncils(CIPCs),onanongoingbasis.ConfidentialandInternal-subjecttoworkscounciland/orunionconsultationsandotherlegalrequirements.冷链分销意味着在适当的时候作出正确的决定Forexample例如：3月13日，一辆冷藏车准备将沛儿疫苗由我公司北京区域经销商处运到北京市郊的疾控中心；在他们仓库人员对其温度观测了约40分钟后，发现车内温度只下降到了12C，于是我们的经销商要求退回了该辆车；两个小时后，另一辆冷藏车到达。8月6日，一辆冷藏车准备装载沛儿疫苗；在刚进行装车的时候车内温度为+5C，但随着外面35C的高温，车内的温度逐渐攀升为15C；经销商当即停止了装载，一个小时过后，当车内的温度又恢复到了+5C后，才继续装载疫苗。7月29日，质量部接到上海商务打来的电话，投诉北京的经销商质量经理拒绝批准在第二天发货到青岛，原因是天气预报预测了第二天北京、青岛等城市高温达40度以上，而青岛的承运商不能保证沛儿疫苗当天可以到达用户，有可能会在某仓库暂存过夜，我们支持了经销商的这种行为。Bettertodelaytheshipmentandguaranteethecoldchain在必要的时候推迟装运以确保冷链的实施NowthatwehavereceivedfinalregulatoryapprovalfortheWyethacquisition,theIntegrationTeamhasauthorizedbusiness,functionalanddivisionalleaderstomakeorganizationalannouncementstosupportbusinesscontinuityandfacilitateourtransitiontoonecompany.ItisimportanttonotethattheseorganizationalchangeswillnotbecomeeffectiveuntilGlobalDayOneortherelevantin-countryGo-Livedate.Untilthattime,PfizerandWyethmustcontinuetooperateastwoseparatecompanies.Theprocessofstaffingandannouncingappointmentsacrossourbusinesseswillvarybymarketandaredependentonemployeeconsultationwithworkscouncilsand/orunionsinsomecountries.ExacttimelineswillalsovarybasedonbusinessneedsandcarefulassessmentbyregionalandlocalleadershipandlocalCountryIntegrationPlanningCouncils(CIPCs),onanongoingbasis.ConfidentialandInternal-subjecttoworkscounciland/orunionconsultationsandotherlegalrequirements.温度要求：2－8℃，根据产品的热稳定性情况稍有偏移举例